EP3207474B1 - Dispositif et procédé de fourniture d'informations de surveillance - Google Patents

Dispositif et procédé de fourniture d'informations de surveillance Download PDF

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Publication number
EP3207474B1
EP3207474B1 EP15778888.6A EP15778888A EP3207474B1 EP 3207474 B1 EP3207474 B1 EP 3207474B1 EP 15778888 A EP15778888 A EP 15778888A EP 3207474 B1 EP3207474 B1 EP 3207474B1
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EP
European Patent Office
Prior art keywords
drug
patient
monitoring information
data
providing device
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EP15778888.6A
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German (de)
English (en)
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EP3207474A1 (fr
Inventor
Murtaza Bulut
Charles Frederik SIO
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Koninklijke Philips NV
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Koninklijke Philips NV
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    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H30/00ICT specially adapted for the handling or processing of medical images
    • G16H30/20ICT specially adapted for the handling or processing of medical images for handling medical images, e.g. DICOM, HL7 or PACS
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/67ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/20ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H70/00ICT specially adapted for the handling or processing of medical references
    • G16H70/40ICT specially adapted for the handling or processing of medical references relating to drugs, e.g. their side effects or intended usage
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/02Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/021Measuring pressure in heart or blood vessels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/02Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/024Detecting, measuring or recording pulse rate or heart rate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/41Detecting, measuring or recording for evaluating the immune or lymphatic systems
    • A61B5/411Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/72Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7271Specific aspects of physiological measurement analysis
    • A61B5/7275Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/74Details of notification to user or communication with user or patient ; user input means
    • A61B5/746Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms

Definitions

  • the present invention relates to a monitoring information providing device and a corresponding monitoring information providing method.
  • Patient monitoring devices (herein also called patient monitors), as often used in hospitals located next to the patient bed, are generally known in the art. They are used as a kind of measurement devices for measuring and displaying of physiological signs and for providing alarming and scoring based on the captured physiological signs. In case a caregiver decides to visit a patient, physiological signs, alarms and scores are available for review.
  • Conventional bedside patient monitors are able to measure and show the patient's physiological signs in real-time. They can also be connected to other devices, such as a PC, enabling caregivers to access and view all information available in the hospital database on a single screen.
  • US 8145590 B2 discloses an expert system for patient medical information analysis.
  • a plurality of chronic sensors is used to facilitate diagnosis and medical decision making for an individual patient.
  • An expert system evaluates the sensor data, combines the sensor data with stored probability data and provides an output signal for notification or medical intervention.
  • WO 2014/091329 A1 discloses a monitoring apparatus for monitoring vital functions of a patient, comprising a connection device connectable to a patient medication storage unit and for receiving information about at least one drug administered to the patient, an interface connectable to a drug database for receiving information about at least one effect of the at least one administered drug and/or a combination of administered drugs, a measurement device associated to the patient for measuring at least one vital parameter of the patient, and a control unit for enabling a measurement of at least one vital parameter and/or for enabling an evaluation of a measurement of at least one vital parameter on the basis of the information about the at least one effect.
  • a monitoring information providing device comprising:
  • a corresponding monitoring information providing method comprising:
  • a computer program which comprises program code means for causing a computer to perform the steps of the method disclosed herein when said computer program is carried out on a computer as well as a non-transitory computer-readable recording medium that stores therein a computer program product, which, when executed by a processor, causes the method disclosed herein to be performed.
  • the present invention is based on the idea to adapt and/or highlight the real-time physiological signs information that is outputted, e.g. shown on a display of a patient monitor, based on drug information. From pharmacology it is known that the drug distribution in body, and consequently the expected effects in terms of physiological signs, depends on absorption and distribution to the site of action. As such, the onset of adverse effects will depend on the administration route (e.g. tablet or intravenous injection) and the affected organ (e.g. a drug in an oral formulation will affect the stomach quickly but the kidneys much later).
  • the administration route e.g. tablet or intravenous injection
  • the affected organ e.g. a drug in an oral formulation will affect the stomach quickly but the kidneys much later.
  • the proposed monitoring information providing device and method support medical personnel towards the right information, so that they can improve the patient care by performing the appropriate checks and delivering the appropriate treatment quicker and more consistently. In a way the proposed device and method make quality of patient care less dependent on the knowledge level of the attending personnel, e.g. a nurse or a doctor. It promotes sharing relevant and up-to-date information quicker, and has the potential to minimize preventable errors in hospitals.
  • conventional drug interaction monitoring systems and software are very generic. They do not provide any (in particular physiological signs and adverse effect) information about the timeline of expected drug effects, or drug-drug interactions, and what to monitor at what time. There is no prioritization of which physiological signs to monitor and at what times, based on expected drug effects or drug-drug interactions.
  • drug-drug interaction e.g. obtained from a drug database, available at the hospital, pharmacy or other drug dispenser, the drug manufacturer or some other place accessible in any way from the monitoring information providing device, for instance via a communications system such as the internet
  • patient data e.g. obtained from patient history databases, such as an electronic health record (EHR) or electronic medical record (EMR) storing historic medical patient data
  • EHR electronic health record
  • EMR electronic medical record
  • physiological signs shall be understood broadly as any signs that relate in any way to the physiology of the patient.
  • the physiological signs include any kinds of vital signs, such as heart rate, blood pressure, respiration rate, SpO2, temperature, etc., but also other signs such as allergic skin reactions, dry mouth, dry eyes, which may also be relevant signs to monitor.
  • the present invention it is proposed to output dynamically adapted monitoring information, e.g. on a display of the monitoring information providing device, a separate display (e.g. of a patient monitoring device), a central surveillance monitor at a nurse station, etc., based on expected adverse reactions due to drug side effects, drug-drug interactions or drug-disease contraindications.
  • the outputted information is time-resolved, which means that the data is updated following the time course of the potential adverse effects, and indicates the clinically most critical physiological signs to pay attention to, i.e. the physiological signs which are important for the particular patient's health state and which, when reaching a critical state, may indicate a serious adverse health state of the patient.
  • the monitoring information may include the physiological signs itself, but may instead or additionally only comprise a list or any other indication (e.g. highlighting) of physiological signs and conditions that are likely to be influenced and that are critical to monitor, without displaying the acquired signals or physiological signs derived there from.
  • the benefits of the present invention are that it makes (or emphasizes) the outputted physiological sign information more relevant to the patient's condition. In preferred embodiments this information may be used to prioritize alarms and/or adapt the alarm thresholds dynamically. In addition to outputting drug-related information, the proposed device and method may suggest and/or automatically initiate additional measurements such as blood pressure in a time-resolved manner, according to the times when blood pressure changes are expected and most relevant.
  • the proposed monitoring information providing device and method may be a stand-alone device and method, respectively, and may be implemented by e.g. a PC, processor or any other hardware comprising the respective means and suitable to carry out the respective steps. Alternatively, they may also be integrated into other devices and methods, e.g. into a patient monitor, a hospital workstation, a doctor's tablet or smartphone, a nurse's monitoring station, etc.
  • the monitoring information providing device further comprises a control unit for generating control information for controlling one or more sensors, which provide sensor signals related to one or more physiological signs that have been determined to be most critical to monitor, to adapt the measurements made by the one or more sensors based on the determined monitoring information.
  • said control unit is configured to generate control information for controlling one or more sensors to start measurement, to perform measurement for a particular time period, to change the measurement frequency and/or to adapt other settings of the measurement based on the determined monitoring information.
  • useful and required sensor signals are provided, which are both drug-related and patient-related and which provide an even further improved overview of the patient's real-time health status over time.
  • the current sensor signals may also be continuously fed to the proposed device and method, e.g. via a sensor interface, to check and, if necessary, adapt the monitoring information.
  • said drug identification input is configured to obtain drug administration data further including the route of administration and/or the amount of the drug administered to the patient. It has been found that this information further improves the accuracy of the determination and dynamic adaption of the monitoring information.
  • said drug identification input is configured to obtain further drug administration data identifying one or more further drugs that have been administered earlier or that will be administered later to the patient and the time of administration of the one or more further drugs, wherein said processing unit is configured to use the further drug administration data in the determination of the monitoring information.
  • said drug identification input is configured to obtain further drug administration data further including the route of administration and/or the amount of the one or more further drugs. This again further improves the accuracy of the determination and dynamic adaption of the monitoring information.
  • the monitoring information providing device further comprises a sensor interface for obtaining one or more sensor signals related to one or more physiological signs of the patient, wherein said processing unit is configured to use the sensor signals in the determination of the monitoring information. This may further improve the accuracy of the monitoring information.
  • the sensor signals may be inputted directly from the respective sensor (e.g. in wired or wireless manner) or indirectly via another device, e.g. via a patient monitor such as a conventional bedside patient monitor.
  • the monitoring information providing device further comprises a food identification input for obtaining food consumption data identifying food consumed by the patient and the time, amount and/or route of consumption of the food by the patient, wherein said processing unit is configured to use the food consumption data in the determination of the expected changes of one or more physiological signs of the patient over time. Since also the consumption of food, e.g. before, during or after the administration of the drug (food not only has an effect if mixed with the drug, but may also have prolonged effects on metabolism and effect), may lead to drug-food interactions, this embodiment further improves the accuracy of the determination of the monitoring information.
  • the monitoring information providing device further comprises an alarm unit for generating and issuing an alarm in case a physiological sign indicated by the determined monitoring information reaches a critical state, wherein said alarm unit is configured to adapt its settings for determining if a physiological sign indicated by the determined monitoring information reaches a critical state based on the determined expected changes of one or more physiological signs of the patient over time.
  • said patient data input is configured to obtain patient data of the monitored patient including the patient's profile, medical history, condition, disease state, co-morbidities, renal and hepatic function, current therapies including non-pharmacological treatments, blood values data and/or other examination data (e.g. imaging, histology of biopsies, etc.).
  • This information may e.g. be obtained from medical records (e.g. EHR) or a hospital database, or may be inputted by the user via a user interface, e.g. a keyboard of a PC or the monitoring information providing device. The use of such information further improves the accuracy of the determination and dynamic adaptation of the monitoring information.
  • the proposed monitoring information providing device further comprises an imaging unit, in particular a camera, for providing image data
  • said patient data input is configured to identify the patient from said image data (e.g. via face recognition)
  • said drug identification input is configured to identify the drug administered to the patient and the time of administration of the drug to the patient from said image data (e.g. via image processing to recognize an identifier attached to the drug container and to recognize the act of administration)
  • said processing unit is configured to determine one or more physiological signs of the patient from said image data (e.g. via the well-known remote photo-plethysmography technique) and to use the sensor signals in the determination of the monitoring information.
  • a user interface e.g. a keyboard or touchscreen
  • a reader may be used, such as an RFID reader or barcode scanner, for reading a corresponding identifier attached to the patient or patient bed for identifying the patient and/or attached to the drug container for identifying the drug.
  • corresponding sensors attached to the patient's body may be used, such as a pulse oximeter, SpO2 sensor, accelerometer (for motion detection and/or respiration rate detection), a breathing rate sensor, a temperature sensor, a blood pressure sensor, ECG electrodes, implantable devices, smart pills, nanotechnology based solutions, etc.
  • Other methods such as sound processing can be used for patient identification and patient status information.
  • the proposed identifications can be done by other means as well, for example using wireless technologies (Wi-Fi, NFC) for patient identification, drug identification or food identification.
  • the monitoring information providing device further comprises an output device, in particular a display, loudspeaker, printer or transmitter, for providing the monitoring information to a user.
  • the monitoring information may be directly outputted at the monitoring information providing device, or may be transmitted (in a wireless or wired manner, e.g. via Bluetooth, Wifi, UMTS, LAN, etc.) to a different device, e.g. a doctor's smartphone or tablet, a monitoring station in a nurse room, a patient monitor, a surveillance center for surveillance of patients at home, etc.
  • the output e.g. the displayed monitoring information, is preferably also dynamically adapted like the monitoring information itself.
  • the different physiological signs may be highlighted or marked in different ways (color, font, etc.) based on how critical they are so that everyone looking at the monitor can immediately understand where to initially focus.
  • the way of highlighting is preferably also changed over time depending on the dynamic adaption of the monitoring information.
  • a storage unit may be provided for storing the monitoring information, and optionally all data that have been outputted or displayed, so that the past time resolved physiological sign monitoring information can be easily accessed if necessary. This makes it possible to go back in time to see what kind of output has been produced earlier. For example, this may be used to check whether meaningful results are currently produced or if some data mining shall be made afterwards.
  • a user interface may be provided for allowing a user to enter data into the device and/or for enabling a user, such as a specialized clinician or another expert, to access specific settings, where he can manually indicate which physiological signs should be critically monitored and when.
  • a user such as a specialized clinician or another expert
  • an option may be given to the user to add more information, update the drug information input, or even to override the automatically determined monitoring information, e.g. automatically determined suggestions which physiological signs to monitor.
  • the device is configured to continuously learn and being adaptive. For example, if it is observed that patient A is sensitive to drug A, after the first administration of drug A, then this knowledge will be used how the critical physiological signs to monitor will be determined next time drug A is given. That is, this new information will be used to adapt the setting of the device, e.g. alarm thresholds, probabilities of adverse effects happening to this patient, etc.
  • Fig. 1 shows a schematic diagram of a first embodiment of a monitoring information providing device 1 according to the present invention. It comprises a patient data input 10 for obtaining patient data of a monitored patient 101, as e.g. provided from a patient data provider 100.
  • a drug identification input 12 is provided for obtaining drug administration data identifying a drug 121 administered to the patient and the time of administration of the drug to the patient, as e.g. provided from a drug administration data provider 120.
  • a drug information input 13 is provided for obtaining drug information of the identified drug (said identification information being included in the drug administration data), e.g. from an external database 130, said drug information including drug side effects and/or drug-drug interactions and/or drug-disease contraindications.
  • a processing unit 14 determines time-resolved monitoring information, said monitoring information being dynamically adapted and indicating one or more physiological signs of the patient that are most critical to monitor over time.
  • An output interface 15 outputs said monitoring information, e.g. to a display 140 for showing this information to a user, e.g. a caregiver, nurse or doctor and/or to a loudspeaker for acoustically issuing such information.
  • This output is preferably made continuously or regularly, e.g. in accordance with the time rhythm in which the monitoring information is dynamically updated.
  • the monitoring information providing device 1 may generally be or integrated into a patient monitor as conventionally used, e.g. as bedside patient monitor.
  • the monitoring information providing device 1 may be a central computer or computer system, to which some or all of the various kinds of obtained data may be provided either directly or indirectly (e.g. via a conventional patient monitor) or a separate device.
  • the monitoring information providing device 1 is stand-alone device that e.g. provides the monitoring information for controlling a patient monitor such as a bedside patient monitor, e.g. in a hospital or a nursing home.
  • the patient data provider 100 may be implemented as a patient identification device, such as an RFID reader or a barcode reader, for reading a patient identifier (e.g. an RFID tag or barcode) attached e.g. to the patient or the patient bed and storing patient identification data (e.g. name, birthday, identification number, etc.). Further, the patient data provider 100 may include a patient database, e.g. an EHR or EMR, storing patient-related data such as the patient's profile, medical history, condition, disease state, co-morbidities, renal and hepatic function, current therapies including non-pharmacological treatments, blood values data and/or other examination data (imaging, histology of biopsies, ...) etc.
  • a patient database e.g. an EHR or EMR
  • patient-related data such as the patient's profile, medical history, condition, disease state, co-morbidities, renal and hepatic function
  • current therapies including non-pharmacological treatments, blood values data and/or other examination data (imagin
  • the patient data input 10 may comprise an interface for coupling a patient identification device to it, for receiving patient data of the identified patient from a remote patient database (e.g. via a (wired or wireless computer network), for entering patient data, etc.
  • the drug administration data provider 120 may be implemented, similar to the patient data provider 100, as a drug identification device, such as an RFID reader or a barcode reader, for reading a drug identifier (e.g. an RFID tag or barcode) attached e.g. to the container holding the drug or the package of the drug, said drug identifier storing drug identification data (e.g. the name of the drug, the producer, etc.).
  • a drug identification device such as an RFID reader or a barcode reader
  • a drug identifier e.g. an RFID tag or barcode
  • the drug information input 13 is provided for obtaining drug information of the identified drug 121, e.g. from an external database 130 as for instance provided by the producer, a medical or pharmaceutical company, healthcare IT company, the distributor, the hospital, or another entity.
  • Said drug database 130 holds drug information including drug effects, drug side effects, drug-drug interactions and/or drug-disease contraindications which are provided to the drug information input 13, which is thus appropriately configured for obtaining these data.
  • the drug data input 12 may comprise an interface for accessing a remote drug database 130, e.g. via a (wired or wireless) computer network, communications network, the internet, in the cloud, etc.
  • the drug database 130 may be held in the monitoring information providing device 1 itself.
  • the barcode of the drugs is preferably scanned at the time of administration. In this way the exact time of drug administration is recorded and stored. Using this information a timeline of the expected course of adverse effects will be automatically calculated by accessing the drug, drug-drug interaction, drug-disease contraindications and patient data.
  • Patients can be also scanned before drug administration (e.g. from identification bracelet IDs, passports, facial recognition etc.) and their medical history may be used to calculate patient-adapted timelines of expected interaction and physiological signs to monitor.
  • drug administration e.g. from identification bracelet IDs, passports, facial recognition etc.
  • medical history may be used to calculate patient-adapted timelines of expected interaction and physiological signs to monitor.
  • measured or calculated physiological signs can be used to automatically assign the patient to predefined patient groups, which can then be used to fine tune the patient-group adapted timeline of expected interactions.
  • automatic parameter classification algorithms such as k-means, neural networks, Hidden Markov Models, etc.
  • the physiological signs data before drug intake can be used to generate clusters of condition before drug intake, such as PreCluster1, PreCluster2, etc.
  • clusters for after drug intake such as PostCluster1, PostCluster2, PostCluster3, can be generated.
  • the likelihood of moving from one PreCluster to one PostCluster can be calculated.
  • the physiological signs can be monitored for specific amount of time (for example 30-60 min, or less when applicable). This data may then be used to assign a patient into one of the PreClusters. Then the monitoring information providing device and method can be used as described above.
  • the historical data and the current measured data are preferably used to determine the PreClusters, and the PostClusters, and also the likelihood of moving from one PreCluster to one PostCluster.
  • the Pre- and Post-clusters may be dynamically adapted.
  • a food identification input 16 may be provided for obtaining food consumption data identifying food consumed by the patient and the time, amount and/or route of consumption of the food by the patient.
  • food 161 can be also identified, e.g. by use of a food data provider 160 which may also be a barcode scanner or RFID reader (or even the same device as the drug administration data provider 120). This information can then be used to predict potential drug-food interactions, the expected adverse effects, their time course, and physiological signs to be monitored.
  • a limited number of critical physiological signs to monitor may be highlighted, e.g. on the display 140, according to the calculated timeline. This will serve as a reminder to the attending staff and provide support in drawing the attention of the attending staff to the particular important information to monitor. Additionally, if space on the displayed screen allows, the drug(s) that cause the potential adverse effect and, optionally, further drug information on these drugs, may be displayed. This information may be updated based on the expected time course of the evolution of the adverse effect and may be removed when the critical period has passed.
  • Fig. 2 shows a schematic diagram of a second embodiment of a monitoring information providing device 2 according to the present invention.
  • a sensor interface 11 is provided for obtaining one or more sensor signals related to one or more physiological signs of the patient, as e.g. provided from one or more sensors 110, 111, 112.
  • the processing unit 14 determines the monitoring information based on the sensor signals (and/or physiological signs derived there from) in addition to the obtained patient data and drug information.
  • the sensors 110, 111, 112 may be separate body-mountable (controllable and/or non-controllable) sensors that are generally attached to the patient's body for measuring sensor signals related to physiological signs of the patient, i.e. which are directly representing a physiological sign (e.g. the temperature obtained from a thermometer) or a used to retrieve a physiological sign (e.g. an ECG signal from which the pulse rate can be retrieved).
  • a physiological sign e.g. the temperature obtained from a thermometer
  • a physiological sign e.g. an ECG signal from which the pulse rate can be retrieved
  • Examples of such sensors include pulse oximeters, SpO2 sensors, accelerometers (for motion detection and/or respiration rate detection), breathing rate sensors, temperature sensors, blood pressure sensors, ECG electrodes, etc.
  • the second embodiment shown in Fig. 2 may also be stand-alone device or integrated into another device.
  • the monitoring information providing device 2 together with the external elements 100, 110-112, 120, 130, 140 may also be regarded as a monitoring information providing system.
  • alterations of the settings of the monitoring information providing device 1 or 2 and/or of any external elements (as e.g. shown in Fig. 1 or 2 ) connected to the monitoring information providing device 1 or 2 may be made based on the determined monitoring information. For instance, based on the expected critical physiological signs the alert settings for physiological signs sensors (e.g. vital signs sensors), camera-interpreted behavior monitors, or other monitoring devices may be altered automatically.
  • a control unit 17 may be provided for generating control information for controlling one or more of the external sensors 110, 111, 112 via the sensor interface 11 to adapt the measurements made by the one or more sensors 110, 111, 112 based on the determined expected changes of one or more physiological signs of the patient over time.
  • the one or more sensors may be controlled to start measurement, to perform measurement for a particular time period, to change the measurement frequency and/or to adapt other settings of the measurement based on the determined expected changes of one or more physiological signs of the patient over time. Surpassing the levels of the current flagged physiological signs may also trigger a higher alert level than normal.
  • the monitoring information providing device 1 or 2 may display instructions for additional monitoring information providing, e.g. to attach pulse oximeter, determine blood pressure every five minutes, check for skin conditions, ask the patient if he feels more pain than usual, which should be followed by the attending staff. Additionally or alternatively, the monitoring information providing device 1 or 2 may also automatically initiate or change parameters of any elements of the system, such as the measurement frequency of selected sensors or physiological monitors (e.g. automated cuff blood pressure devices).
  • additional monitoring information providing e.g. to attach pulse oximeter, determine blood pressure every five minutes, check for skin conditions, ask the patient if he feels more pain than usual, which should be followed by the attending staff.
  • the monitoring information providing device 1 or 2 may also automatically initiate or change parameters of any elements of the system, such as the measurement frequency of selected sensors or physiological monitors (e.g. automated cuff blood pressure devices).
  • Fig. 3 shows a schematic diagram of a third embodiment of a monitoring information providing device 3 according to the present invention.
  • an imaging unit 170 such as a camera, is provided which takes over the tasks of several of the external elements shown in Fig. 1 or 2 .
  • the imaging unit 170 may replace at least part of the patient data provider 100 by identifying within one or more acquired images the patient 101, either directly by use of a person recognition algorithm, e.g. face recognition, or indirectly by identifying a tag (e.g. a barcode or name tag) attached to the patient or somewhere near the patient. This identification can e.g. be made by the imaging unit 170, the patient data input 10 or the processing unit 14. Other patient data, like the patient profile, the medical history, current patient status, etc. may either be available within the monitoring information providing device 1 or 2 or may be retrieved by the patient data input 100 from a database 102, e.g. the hospital's patient database.
  • a database 102 e.g. the hospital's patient database.
  • the imaging unit 170 may replace the drug administration data provider 120 by identifying within one or more acquired images the drug 121, either directly by use of a drug recognition algorithm, e.g. sample or package recognition, or indirectly by identifying a tag (e.g. a barcode or name printed on the drug container or the package). This identification can e.g. be made by the imaging unit 170, the drug data input 12 or the processing unit 14.
  • a drug recognition algorithm e.g. sample or package recognition
  • a tag e.g. a barcode or name printed on the drug container or the package.
  • the imaging unit 170 may replace the food data provider 160 by identifying within one or more acquired images the food 160, either directly by use of a food recognition algorithm, e.g. sample or package recognition, or indirectly by identifying a tag (e.g. a barcode or name printed on the food container or the package). This identification can e.g. be made by the imaging unit 170, the food data input 16 or the processing unit 14.
  • a food recognition algorithm e.g. sample or package recognition
  • a tag e.g. a barcode or name printed on the food container or the package. This identification can e.g. be made by the imaging unit 170, the food data input 16 or the processing unit 14.
  • the imaging unit 170 may replace one or more of the sensors 110, 111, 112.
  • heart rate, SpO2 and respiration rate can be derived from a time series of images of the patient by use of the well-known remote photo-plethysmography (remote PPG) technology so that corresponding body-mounted sensors can be replaced.
  • Other sensors like a blood pressure sensor 110, may, however, not easily be replaced.
  • the determining of physiological signs of the patient from the images may either be performed directly within the imaging, but is preferably performed by either the sensor interface 11 or the processing unit 15 (or an additional separate unit not shown in Fig. 2 ) is configured to determine one or more physiological signs of the patient from said image data.
  • FIG. 4 A flow chart of an embodiment of the proposed monitoring information providing method 200 is shown Fig. 4 .
  • patient data of a monitored patient are obtained.
  • drug administration data identifying a drug administered to the patient and the time of administration of the drug to the patient are obtained.
  • drug information of the identified drug are obtained, said drug information including drug side effects and/or drug-drug interactions and/or drug-disease contraindications.
  • monitoring information is determined based on the obtained patient data, drug administration data and drug information.
  • the determined monitoring information is outputted.
  • This monitoring information providing method may have further embodiments and options similar as explained above with respect to the monitoring information providing device. Further, the chronological sequence of the first three steps S10, S12, S14 may also be different, e.g. the second and third steps S12, S14 may be performed before the first step S10.
  • Fig. 5 shows a schematic diagram of a fourth embodiment of a monitoring information providing device 4 according to the present invention.
  • Many of the elements provided in the first and second embodiments as shown in Figs. 1 , 2 and 3 are provided in this embodiment as well.
  • part of the tasks of the patient data input 10 and/or the drug information input 13 are performed by a common data input 18.
  • This data input 18 is coupled to an external system 150, which may be an external computer system, e.g. of the hospital computer system, or a central workstation, or an external personal computer.
  • This external system 150 is able to access one or more databases to retrieve information required by the monitoring information providing device 4.
  • the patient database 102 e.g.
  • a drug database 130 may be accessed to obtain drug information for the identified drug.
  • a food database (not shown) may be accessed optionally, if food intake is also identified by the monitoring information providing device.
  • the external system 150 may also take over further tasks, e.g. the task of patient identification, drug identification and/or food identification based on image data (if such are available as in the third embodiment of the monitoring information providing device 3) by use of image processing or the task of calculating patient-related alarm limits for physiological signs to be monitored, etc.
  • further tasks e.g. the task of patient identification, drug identification and/or food identification based on image data (if such are available as in the third embodiment of the monitoring information providing device 3) by use of image processing or the task of calculating patient-related alarm limits for physiological signs to be monitored, etc.
  • the monitoring information providing device 4 may be designed like a conventional monitoring information providing device and may include a monitor 19, representing the output interface. Generally, other additional information apart from the information mentioned above may be displayed, such as calculated health scores, ECG curves, patient data, warnings, etc.
  • an alarm unit 20 may be provided for generating and issuing an alarm (e.g. visually and/or audible) in case a physiological sign reaches a critical state.
  • said alarm unit 20 is configured to adapt its settings (or is being controlled to adapt its settings) for determining if a physiological sign reaches a critical state based on the determined expected changes of one or more physiological signs of the patient over time. Such alarms (and optionally the settings) may also be displayed on the monitor 19.
  • a storage unit 21 may be provided for storing the monitoring information, and optionally all data that have been outputted or displayed, so that the time resolved physiological signs feedback can be easily accessed if necessary.
  • a user interface 22 may be provided for allowing a user to enter data into the device and/or for enabling a user, such as a specialized clinician or another expert, to access specific settings, where he can manually indicate which physiological signs should be critically monitored and when. In other words, the user to add more information or even to override the automatically determined monitoring information, e.g. automatically determined suggestions which physiological signs to monitor.
  • antibiotics are commonly used to prevent or treat infections.
  • antibiotics of the penicillin and cephalosporin class carry a risk of allergic reactions.
  • Serious allergic reactions can have a very quick onset of seconds to minutes upon start of administration, and require immediate medical treatment. They may occur the first time a patient ever receives the drug, but also even after the patent has been given the drug before without any problems.
  • Life-threatening anaphylactic shock presents itself mainly as a drop in blood pressure which then triggers a reflex increased heart rate, and/or edema in the respiratory tract causing respiratory distress, followed by loss of consciousness and occasionally death. Other effects will present themselves as well but are less life-threatening.
  • a patient shall be considered who will receive penicillin by infusion.
  • IV intravenous
  • a nurse or even better a doctor, would continuously monitor the patient for the first 15 minutes, but this is often impossible in daily practice. Rather, the attending nurse will try to give extra attention to the patient while doing other tasks, but may also be distracted by other medical urgencies.
  • the nurse will interpret the situation and taking appropriate action if needed, and alert the doctor, but not all nurses will be able to interpret every situation.
  • a feedback from a practicing medical doctor regarding the aforementioned statement is the following: "Yes, very true. There may also be an advantage of detecting an early trend, or combination of trends. A nurse (who is ultimately the person administrating the drug) does not always have the knowledge to interpret physiological signs. Keeping a doctor at the bedside is too expensive.” Such situations can e.g. be improved by use of the present invention as follows.
  • the barcode of the IV bag with antibiotics is scanned, as well as the identification tag of the patient and/or the patient monitor.
  • the medication alert system will check for a pre-existing penicillin allergy for this patient and issue a medication alert, e.g. at a central monitor (e.g. at the pharmacy or at the central nurse station), if this is found.
  • a central monitor e.g. at the pharmacy or at the central nurse station
  • the proposed monitoring information providing device may in addition also display this alert on the display at the monitoring information providing device and/or give an auditory alarm at the monitoring information providing device, i.e. right at the patient's location.
  • the drug information is often entered into the system at a central location (pharmacy, central nurse station).
  • the present invention provides the functionally of doing this at the patient side, which also means that alarms can be also displayed on the patient monitors as well as central monitors.
  • the proposed monitoring information providing device will display on the display at the monitoring information providing device the three main physiological signs of a life-threatening anaphylactic reaction that currently need to be checked with priority, i.e. increased heart rate, decreased blood pressure and respiratory difficulty.
  • temperature measurements and skin reactions can be also analyzed and taken into account. For example, since skin reactions are present in 90% of the anaphylactic situations, the information displayed at the monitoring information providing device can include suggestions for these checks.
  • Such information may also be presented for 15 minutes. After this time the risk of serious side effects for this medication administration is gone, and maintaining the information on the screen will only distract staff.
  • the proposed monitoring information providing device will advise high frequency blood pressure measurements (every minute if possible) for the coming 15 minutes, or initiate these if automatic blood pressure devices are in place.
  • the proposed monitoring information providing device After 15 minutes the proposed monitoring information providing device resets to normal.
  • the information on the display at the monitoring information providing device is removed, automatic high frequency blood pressure measurements - if initiated - are set back to normal frequency, physiological signs are no longer monitored for trend - unless this was already the case - and violations of threshold levels will trigger normal alarms, not high level priority alarms.
  • Olanzapine is an antipsychotic, used to treat schizophrenia and sometimes also to decrease acute agitation.
  • Use of benzodiazepines such as valium is also common in these patients, however combined the two may lead to severe hypotension, oversedation, cardiorespiratory depression, which has been on occasion fatal.
  • a doctor should not give injections of valium for at least one hour.
  • a patient who has been given valium should only be given intramuscular olanzapine under close monitoring.
  • an agitated patient shall be considered who is brought into the ER.
  • the patient is given haloperidol but does not respond.
  • the patient receives an intramuscular injection of olanzapine.
  • the barcode is read at time of administration.
  • the patient responds only partially and later on the patient is given an injection of valium, which is also entered into the monitoring information providing device by reading of the barcode.
  • valium is given more than 1 hour after the olanzapine. In this case no alert is created.
  • the valium is given within one hour after the olanzapine.
  • an alert may be created on a central monitor of the system. This comprises which drugs are involved and the adverse effect which may be expected.
  • the monitoring information providing device may also create an alert on the bedside monitor of the patient, stating the three main physiological signs to watch: lowered blood pressure, lowered breathing frequency, severely lowered consciousness level. A nurse or doctor who notices a change in these physiological parameters will raise an alarm so that appropriate action is taken, even if they do not know the particular situation of this patient, or do not know the exact interaction effects of this particular drug-drug interaction. After a set amount of time, e.g. two hours, these physiological signs are automatically removed, as there is no longer an immediate danger from these medications.
  • the valium is given within one hour, but in addition a friend of the patient who came by has given the information that the patient has had alcoholic drinks that evening.
  • This information is also entered into the monitoring information providing device.
  • a higher level priority alarm is generated and the monitoring information providing device advises to attach a pulse-oximeter to monitor blood oxygenation, if not already present.
  • the monitoring information providing device automatically sets a more stringent alarm level to the blood oxygenation level, and if it drops below this threshold a high level priority alert will be generated at the monitoring information providing device and the nurse's station, as the patient is likely going into respiratory distress.
  • the present invention proposes to generate and output, in particular display, dynamically adapting information on a monitoring information providing device, which information is changing based on expected adverse reactions due to drug side effects, drug-drug interactions or drug-disease contraindications.
  • the outputted information is time-resolved, which means that the data is updated following the time course of the potential adverse effects, and comprises the most important physiological signs to pay attention to.
  • the benefits of the invention are that it makes the outputted physiological sign information and consequently the alarms more relevant to the patients' condition. If desired this information can be used to prioritize the alarms and adapt the alarm thresholds dynamically.
  • the proposed monitoring information providing device can automatically initiate additional measurements - such as blood pressure - in a time-resolved manner, according to the times when pivotal changes (e.g., in blood pressure) are expected.
  • a computer program may be stored/distributed on a suitable non-transitory medium, such as an optical storage medium or a solid-state medium supplied together with or as part of other hardware, but may also be distributed in other forms, such as via the Internet or other wired or wireless telecommunication systems.
  • a suitable non-transitory medium such as an optical storage medium or a solid-state medium supplied together with or as part of other hardware, but may also be distributed in other forms, such as via the Internet or other wired or wireless telecommunication systems.

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Claims (15)

  1. Dispositif de fourniture d'informations de surveillance (1) comprenant :
    - une entrée de données de patient (10) pour obtenir des données d'un patient surveillé,
    - une entrée d'identification de médicament (12) pour obtenir des données d'administration de médicament identifiant un médicament administré au patient et le temps d'administration du médicament au patient,
    - une entrée d'informations de médicament (13) pour obtenir des informations sur le médicament identifié, lesdites informations de médicament comprenant les effets secondaires du médicament et/ou les interactions médicament-médicament et/ou les contre-indications médicament-maladie,
    - une unité de traitement (14) pour déterminer les informations de surveillance résolues dans le temps sur la base des données de patient, des données d'administration de médicament et des informations de médicament obtenues, lesdites informations de surveillance étant adaptées de manière dynamique et indiquant un ou plusieurs signes physiologiques du patient qui sont les plus critiques à surveiller au fil du temps et
    - une interface de sortie (15, 19) pour délivrer lesdites informations de surveillance déterminées.
  2. Dispositif de fourniture d'informations de surveillance selon la revendication 1,
    dans lequel l'unité de traitement (14) est configurée pour déterminer des informations de surveillance indiquant en outre
    - à quel moment des changements de signes physiologiques sont attendus,
    - dans quel mesure les changements sont attendus,
    - le niveau critique des changements respectifs,
    - les effets secondaires de médicament, les interactions médicament-médicament, les contre-indications médicament-maladie et/ou les interactions médicament-aliments potentiels qui peuvent apparaître et/ou
    - dans quelle mesure ces effets secondaires de médicament, interactions médicament-médicament, contre-indications médicament-maladie et/ou interactions médicament-aliments potentiels sont censés provoquer des changements de signes physiologiques, à quel niveau les changements sont attendus et/ou le niveau critique des changements respectifs.
  3. Dispositif de fourniture d'informations de surveillance selon la revendication 1,
    comprenant en outre une unité de commande (17) pour générer des informations de commande pour commander un ou plusieurs capteurs (110, 11, 112) qui fournissent des signaux de capteurs rapportés à un ou plusieurs signes physiologiques qui ont été déterminés comme étant les plus critiques à surveiller pour adapter les mesures effectuées par les un ou plusieurs capteurs (110, 111, 112) sur la base des informations de surveillance déterminées.
  4. Dispositif de fourniture d'informations de surveillance selon la revendication 3,
    dans lequel ladite unité de commande (17) est configurée pour générer des informations de commande pour commander un ou plusieurs capteurs (110, 111, 112) afin de démarrer la mesure, effectuer la mesure sur une période de temps particulière, changer la fréquence de mesure et/ou adapter d'autres réglages de la mesure sur la base des informations de surveillance déterminées.
  5. Dispositif de fourniture d'informations de surveillance selon la revendication 1, dans lequel ladite entrée d'identification de médicament (12) est configurée pour obtenir des données d'administration de médicament comprenant en outre la voie d'administration et/ou la quantité du médicament administrée au patient.
  6. Dispositif de fourniture d'informations de surveillance selon la revendication 1,
    dans lequel ladite entrée d'identification de médicament (12) est configurée pour obtenir d'autres données d'administration de médicament identifiant un ou plusieurs autres médicament qui a ou ont été administrés précédemment ou qui sera ou seront administrés plus tard au patient et le temps d'administration des un ou plusieurs autres médicaments et
    dans lequel ladite unité de traitement (14) est configurée pour utiliser les autres données d'administration de médicament dans la détermination des informations de surveillance.
  7. Dispositif de fourniture d'informations de surveillance selon la revendication 6,
    dans lequel ladite entrée d'identification de médicament (12) est configurée pour obtenir d'autres données d'administration de médicament comprenant en outre la voie d'administration et/ou la quantité des un ou plusieurs autres médicaments.
  8. Dispositif de fourniture d'informations de surveillance selon la revendication 1,
    comprenant en outre une entrée d'identification d'aliment (16) pour obtenir des données de consommation d'aliment identifiant l'aliment consommé par le patient et le moment, la quantité et/ou la voie de consommation de l'aliment par le patient,
    dans lequel ladite unité de traitement (14) est configurée pour utiliser les données de consommation d'aliment dans la détermination des informations de surveillance.
  9. Dispositif de fourniture d'informations de surveillance selon la revendication 1,
    comprenant en outre une unité d'alarme (20) pour générer et délivrer une alarme dans le cas où un signe physiologique indiqué par les informations de surveillance déterminées atteint un état critique, dans lequel ladite unité d'alarme (20) est configurée pour adapter ses réglages pour déterminer si un signe physiologique indiqué par les informations de surveillance déterminées atteint un état critique sur la base des informations de surveillance déterminées.
  10. Dispositif de fourniture d'informations de surveillance selon la revendication 1,
    dans lequel ladite entrée de données de patient (10) est configurée pour obtenir des données de patient du patient surveillé comprenant le profil du patient, l'historique médical, l'état, le niveau de maladie, les co-morbidités, les fonctions rénale et hépatique, les thérapies courantes incluant des traitements non pharmacologiques, des données de valeurs sanguines et/ou d'autres données d'examen.
  11. Dispositif de fourniture d'informations de surveillance selon la revendication 1,
    comprenant en outre une interface de capteur (11) pour obtenir un ou plusieurs signaux de capteur rapportés à un ou plusieurs signes physiologiques du patient, dans lequel ladite unité de traitement (14) est configurée pour utiliser les signaux de capteur dans la détermination des informations de surveillance.
  12. Dispositif de fourniture d'informations de surveillance selon la revendication 1,
    comprenant en outre une unité d'imagerie (170), en particulier une caméra, pour fournir des données d'images, dans lequel
    ladite entrée de données de patient (10) est configurée pour identifier le patient à partir desdites données d'image et/ou
    ladite entrée d'identification de médicament (12) est configurée pour identifier le médicament administré au patient et le temps d'administration du médicament au patient à partir desdites données d'images et/ou
    ladite unité de traitement (14) est configurée pour déterminer un ou plusieurs signes physiologiques du patient à partir desdites données d'image et pour utiliser les signaux de capteur dans la détermination des informations de surveillance.
  13. Dispositif de fourniture d'informations de surveillance selon la revendication 1,
    comprenant en outre un dispositif de sortie (140), en particulier un appareil d'affichage, un haut-parleur, une imprimante ou un transmetteur, pour fournir les informations de surveillance à un utilisateur.
  14. Procédé de fourniture d'informations de surveillance (200) comprenant :
    - l'obtention de données d'un patient surveillé (S10),
    - l'obtention de données d'administration de médicament identifiant un médicament administré au patient et le temps d'administration du médicament au patient (S12),
    - l'obtention d'informations du médicament identifié, lesdites informations de médicament comprenant les effets secondaires du médicament et/ou les interactions médicament-médicament et/ou les contre-indications médicament-maladie (S14),
    - la détermination (S16) d'informations de surveillance résolues dans le temps sur la base des données de patient, des données d'administration de médicament et des informations de médicament obtenues, lesdites informations de surveillance étant adaptées par voie dynamique et indiquant un ou plusieurs signes physiologiques du patient qui sont les plus critiques à surveiller au fil du temps et
    - la délivrance (S18) d'informations aux informations de surveillance déterminées.
  15. Programme informatique comprenant des moyens de codage de programme pour amener un ordinateur à effectuer les étapes du procédé selon la revendication 14, lorsque ledit programme informatique est effectué sur l'ordinateur.
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US10216900B2 (en) 2019-02-26
JP2018500623A (ja) 2018-01-11
JP6865162B2 (ja) 2021-04-28
EP3207474A1 (fr) 2017-08-23
US20160103967A1 (en) 2016-04-14
WO2016058807A1 (fr) 2016-04-21
MX2017004620A (es) 2017-06-30
CN106796622A (zh) 2017-05-31

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